Cassiopea Announces FDA Acceptance of its New Drug Application for Clascoterone Cream 1%, the First New Mechanism of Action for Acne in Nearly 40 Years
Cassiopea SpA, a specialty pharmaceutical company developing and commercializing prescription drugs with novel mechanisms of action (MOA) to address long-standing and essential dermatological conditions, announced today the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for clascoterone cream 1%. Cassiopea is seeking marketing approval for clascoterone cream 1% for the treatment of acne. The FDA has set August 27, 2020 as the Prescription Drug User Fee Act (PDUFA) action date.